Review

Food and Nutrition Bulletin

2018, Vol. 39(2) 315-331
ª The Author(s) 2018
Large-Scale Food Fortification
and Biofortification in Low- Reprints and permission:
sagepub.com/journalsPermissions.nav
DOI: 10.1177/0379572118774229
and Middle-Income Countries: journals.sagepub.com/home/fnb

A Review of Programs, Trends,

Challenges, and Evidence Gaps

Saskia J. M. Osendarp, PhD1,2, Homero Martinez, MD, PhD2,3 ,

Greg S. Garrett, MSc4, Lynnette M. Neufeld, PhD4,
Luz Maria De-Regil, PhD3, Marieke Vossenaar, PhD2,
and Ian Darnton-Hill, MD, PhD5,6

Abstract
Background: Food fortification and biofortification are well-established strategies to address
micronutrient deficiencies in vulnerable populations. However, the effectiveness of fortification pro-
grams is not only determined by the biological efficacy of the fortified foods but also by effective and
sustainable implementation, which requires continual monitoring, quality assurance and control, and
corrective measures to ensure high compliance.
Objective: To provide an overview of efficacy, effectiveness, economics of food fortification and
biofortification, and status of and challenges faced by large-scale food fortification programs in low- and
middle-income countries (LMIC).
Methods: A literature review of PubMed publications in English from 2000 to 2017, as well as gray
literature, targeting nongovernmental organizations whose work focuses on this topic, complemented
by national reports and a “snowball” process of citation searching. The article describes remaining
technical challenges, barriers, and evidence gap and prioritizes recommendations and next steps to
further accelerate progress and potential of impact.
Results: The review identifies and highlights essential components of successful programs. It also
points out issues that determine poor program performance, including lack of adequate monitoring
and enforcement and poor compliance with standards by industry.

1
Osendarp Nutrition, Berkel & Rodenrijs, the Netherlands
2
Micronutrient Forum, Ottawa, Ontario, Canada
3
Nutrition International, Ottawa, Ontario, Canada
4
Global Alliance for Improved Nutrition (GAIN), Geneva, Switzerland
5
Institute of Obesity, Nutrition and Exercise, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
6
Friedman School of Nutrition Science and Policy, Tufts University, MA, USA

Corresponding Author:
Homero Martinez, Nutrition International, 180 Elgin St. Suite 1000, Ottawa, Ontario, Canada K2P 2K3.
Email: hmartinez@nutritionintl.org
316 Food and Nutrition Bulletin 39(2)

Conclusions: In the last 17 years, large-scale food fortification initiatives have been reaching
increasingly larger segments of populations in LMIC. Large-scale food fortification and biofortification
should be part of other nutrition-specific and nutrition-sensitive efforts to prevent and control
micronutrient deficiencies. There are remaining technical and food system challenges, especially in
relation to improving coverage and quality of delivery and measuring progress of national programs.

Keywords
large-scale food fortification, biofortification, low- and middle-income countries, economics,
compliance

Introduction Food fortification is a sound public health

Deficiencies of micronutrients (vitamins and
minerals/trace elements), and the resulting nega-
tive health consequences of such deficiencies,
affect over an estimated 2 billion people globally.1
The most common forms of micronutrient defi-
ciencies include iron, iodine, vitamin A, zinc, and
folate.1 The most vulnerable populations include
reproductive-aged women, young children, and
female adolescents, particularly in LMIC.2,3
Micronutrient malnutrition or “hidden hunger”
has significant health and economic conse-
quences.4-7 Just in LMIC, micronutrient defi-
ciencies alone have been estimated to cost an
annual gross domestic product loss of 2% to
5%8-11 with direct costs estimated between
US$20 and US$30 billion every year.10 Anemia,
for example, has been estimated to lead to 17%
reduced lower productivity in heavy manual
labor and an estimated 2.5% loss of earnings due
to lower cognitive skills.9
The World Health Organization (WHO) and
the United Nations Food and Agriculture Organi-
zation (FAO) have identified 4 main strategies for
addressing micronutrient malnutrition: nutrition
education leading to increased diversity and
quality of diets, food fortification and biofortifi-
cation, supplementation, and disease control
measures.12 Each of these strategies has a place
in reducing micronutrient malnutrition. For
maximum impact, the appropriate mix of these
strategies should be in place simultaneously to
promote equity in access to interventions and
social mechanisms that allow consumption and
utilization of an adequate diet for all people in
the world.12
strategy because it can reach large segments of
at-risk populations through existing food delivery
systems, without requiring major changes in exist-
ing consumption patterns.13 Compared to other
interventions, food fortification is likely to be
more cost-effective, and if fortified foods are reg-
ularly consumed, there is an advantage of main-
taining consistent physiological body stores of
certain micronutrients used in the fortification.12
Large-scale food fortification programs have
been in place in industrialized countries since the
early 20th century and have helped to eliminate
deficiency diseases in high-income countries,
mainly in North America and Europe.4,14 More
recently, food fortification has gained traction in
LMIC as well, and its health impact in these
countries is growing.15 However, the effective-
ness of fortification programs is not only deter-
mined by the biological efficacy of the fortified
food but also by its effective implementation,
which includes among others monitoring, quality
assurance (QA)/quality control (QC) followed by
correction of identified issues, as well as compli-
ance by industry with the fortifications standards.
In 2006, the WHO published guidelines for
effective fortification, including the appropriate
selection of food vehicles and fortificants, deter-
mining fortification concentrations, and imple-
menting effective and sustainable food
fortification programs.12 In September 2015, the
#Future Fortified Global Summit on Food Forti-
fication was held in Arusha, Tanzania, to discuss
the state of the art on achievements and chal-
lenges in large-scale food fortification in LMIC.
The Arusha Summit aimed to develop a consen-
sus among key global stakeholders around a
Osendarp et al
vision and strategy for scaling up fortification that
would, in turn, contribute to the Sustainable
Development Goals and beyond.15 The resulting
“Arusha Statement on Food Fortification” (http://
www.gainhealth.org/wp-content/uploads/2015/
05/Arusha-Statement.pdf) summarized commit-
ments to address remaining challenges around
monitoring, compliance, and equity. It also out-
lined 5 critical areas needing to be addressed for
immediate progress: (1) modest but new invest-
ments by governments and donors to ensure
technical support and capacity, compliance, and
leveraging coinvestment by the private sector;
(2) improving the oversight and enforcement of
food fortification standards and legislation; (3)
generating more evidence to demonstrate impact
and further guide fortification policy and pro-
gram design; (4) more transparent accountability
and global reporting; and (5) continuing advo-
cacy for greater attention to fortification by
governments.15
As part of the global response to the Arusha
Statement, this article will provide an overview of
efficacy, effectiveness, and economics of food
fortification and biofortification, as well as an
analysis of the overall status of large-scale food
fortification programs in LMIC. The article is
based on 2 detailed review reports published in
the aftermath of the Arusha meeting. 16,17 It
reviews and identifies essential components of
successful programs, points out issues around the
frequent lack of adequate compliance, and
describes remaining technical challenges, bar-
riers, and evidence gaps. It then uses this infor-
mation to prioritize recommendations and next
steps, with a focus on mass fortification of sta-
ples, edible fats and oils, sugar, and condiments
(including salt). In addition, it reviews the current
evidence base and promise of biofortification
efforts in LMIC.
Methods
A literature review of both formal and gray liter-
ature was conducted, targeting nongovernmental
organizations whose work focuses on this topic,
including the Food Fortification Initiative (FFI),
the Global Alliance for Improved Nutrition
(GAIN), Nutrition International (NI), and the
317
Iodine Global Network (IGN), complemented
by national reports. This work was underpinned
by a formal literature search, focusing on articles
and reports from 2000 to 2017, in English only.
Keywords used were “Fortified food*,”
“Enriched food*,” “Supplemented food*,” and
for Medical Subject Headings (MeSH)-Medline
(via OvidSP) “Food, fortified//adverse effects.”
Complementary keywords were “Government
program*,” “Government sponsored program*,”
“Nutritional policy,” “Government health
promotion,” “Food fortification program*,”
“Policymaker*,” “Health policy*,” “Mandatory
program*,” and under MeSH were “Health
promotion/og,” “Nutrition policy/,” “Health
policy/,” “Mandatory programs/,” “Policy
making,” and “Legislation, Food/.” In addition,
references were added by a process of forwarding
citation searching: for example, identifying rele-
vant references of key articles such as the WHO/
FAO 2006 guidelines,12 following them up, and
then repeating the process with each article used.
Results
Efficacy of Food Fortification
The efficacy of food fortification has been
demonstrated consistently for different micronu-
trients and different food vehicles.6,12 As a result,
it is now well accepted that micronutrient fortifi-
cation of foods has the potential to significantly
increase serum micronutrient concentrations and
reduce clinical and physiological manifestations
of deficiencies.18,19 A systematic review of ran-
domized and pseudorandomized controlled trials
included 60 acceptable trials on iron fortification
and iron biofortification and found that iron for-
tification of foods resulted in a significant
increase in hemoglobin (0.42 g/dL, 95% confi-
dence interval [CI]: 0.28-0.56) and serum ferritin
(1.36 mg/L; 95% CI: 1.23-1.52), a reduced risk of
anemia (risk ratio [RR]: 0.59; 95% CI: 0.48-
0.71), and iron deficiency (RR: 0.48; 95% CI:
0.38-0.62); no effect was found on rate of infec-
tions, physical growth, or mental and motor
development.20 The efficacy of rice fortification
with iron has been demonstrated in different
settings.21-23 In Mexico, daily consumption of
318
iron-fortified rice 5 d/wk over a 6-month period
significantly increased body iron stores and mean
plasma ferritin concentration in working women
between 18 and 49 years of age and improved
hemoglobin concentration of women with ane-
mia, resulting in an overall reduction of the pre-
valence of anemia of 80%.21 Fortification of
wheat flour with folic acid has been widely
shown to significantly improve folate status in
the population, and its significant effect in reduc-
ing the risk of neural tube defects (NTDs) has
been repeatedly documented and is now widely
accepted.24,25 Efficacy of vitamin A fortification
has been documented in the Philippines, where
monosodium glutamate, 26 margarine, 27 and
wheat buns are fortified with this vitamin.28 The
efficacy of multiple micronutrient fortification
has been demonstrated in studies with iron, b-
carotene, and iodine-fortified biscuits in South
Africa and multiple micronutrient-fortified bev-
erages in Botswana and Tanzania.12
Condiments, spices, and seasonings are
increasingly being used as vehicles to increase
the intake of vitamins and minerals.29 Mandatory
or market-driven condiment fortification with
iron has been used with various vehicles such as
soy sauce, fish sauce, salt, and bouillon cubes.12
Until now, most of the experience with fortifica-
tion of condiments and seasonings has been with
NaFe-EDTA added to soy and fish sauces in
Southeast Asian countries. Other condiments,
such as bouillon cubes or curry powders, are now
also being fortified with iron and other vitamins
and minerals.29 A recent systematic review has
demonstrated that iron fortification of condiments
is associated with increased hemoglobin,
improved iron status, and reduced anemia across
targeted populations.30
Efficacy of Biofortification
Evidence for the efficacy of biofortified crops in
improving micronutrient status has been docu-
mented in different studies, particularly for vita-
min A–biofortified crops, as summarized in a
review of evidence from Harvest Plus by Bouis
and Saltzman.31 The first efficacy data on biofor-
tification came from studies demonstrating that
consumption of vitamin A–biofortified orange-
Food and Nutrition Bulletin 39(2)
fleshed sweet potato increased circulating b-car-
otene and had a moderate effect on vitamin A
status. 31 Biofortified provitamin A maize
improved total body stores of vitamin A in 5- to
7-year-old children in Zambia and significantly
improved visual function in deficient children.32
In Kenya, provitamin A cassava was efficacious
in improving vitamin A status of schoolchil-
dren.33 Iron-biofortified beans and pearl millet
improved hemoglobin and total body iron stores
in Rwanda and Maharashtra, India.31 Biofortifi-
cation with other micronutrients, such as
zinc-biofortified wheat or rice, has shown to be
feasible and to offer bioavailable zinc, but as yet
there are no efficacy trials.31
Effectiveness of Food Fortification
In high-income countries, food fortification has
been largely responsible for the control or elim-
ination of several micronutrient deficiency dis-
eases of public health significance. For instance,
marked declines in the prevalence of pellagra
from niacin deficiency and beriberi from thia-
mine deficiency were observed in the Southern
United States and Canada, respectively, after vol-
untary and mandatory fortification of flours and
bread with high-vitamin yeast.4,14 In the United
States, mandatory large-scale fortification of
enriched cereal grain products with folic acid was
authorized in 1996 and fully implemented in
1998. Within 5 years, the prevalence of NTDs
was dramatically reduced to around 0.66 in
1000 pregnancies or less.34 Fortification of cereal
grain products with folic acid became mandatory
in several countries soon after and has been con-
sistently effective in reducing the prevalence of
NTDs to around 0.5  1000 total births in coun-
tries where it has been implemented.12,35-37 Man-
datory addition of vitamin D to milk, which
started in 1965 in Canada, eliminated the wide-
spread problem of childhood rickets.14 Salt iodi-
zation, in place since the 1920s in Switzerland
and the United States and rapidly expanding in
LMIC, has reduced goiter prevalence globally,
and universal salt iodization (USI) has prevented
an estimated 750 million cases of goiter in the
past 25 years.38 After the introduction of vitamin
A–fortified margarine in Denmark in 1917, the
Osendarp et al
number of cases of xerophthalmia reported at
Copenhagen Hospital fell by more than 90% and
had been eliminated by 1918.39,40
Pachon et al41 recently published the first sys-
tematic review of evidence of the effect of flour
fortification on iron status and anemia in women
and children 15 years in LMIC. They identified
only 13 large-scale flour fortification programs
that collected national-level data before fortifica-
tion and 12 months after fortification. Their
analysis found that flour fortification was associ-
ated with consistent reductions in low ferritin pre-
valence in one-third of women but not in children.
Also, there was statistically significant reduction
of anemia in 4 of 12 subgroups of women and 4 of
13 subgroups of children.41 This study recognized
several caveats, including lack of use of an ade-
quate program design to evaluate effectiveness, a
large heterogeneity in implementation, and lack
of adequate use of biological markers to evaluate
impact.41,42 The authors also mention the fact that
anemia may be due to many other causes different
from iron deficiency. As a way to address this last
point, Barkley et al43 evaluated if anemia preva-
lence was reduced in LMIC that fortified wheat
flour, alone or in combination with maize flour,
with at least iron, folic acid, vitamin A, or vitamin
B12, comparing nationally representative data
before/after fortification started. In the 12 coun-
tries that had fortified, there was a 2.4% reduction
in the odds of anemia prevalence, in comparison
with no reduction in the odds of anemia preva-
lence in 20 countries that never fortified flour.43
In several Latin American countries, vitamin
A–fortified sugar has been effective in reducing
vitamin A deficiencies.44 In Guatemala, where
the technology for fortifying sugar with vitamin
A was developed, an evaluation of the fortifica-
tion program carried out showed that after
12 months of implementation, low retinol levels
had decreased to 5% and prevalence of human
milk samples with less than 20-mg retinol/dL was
reduced by 50%.45,46 A recent systematic evalua-
tion of 76 studies and 41 contextual reports15
concluded that there is strong evidence of impor-
tant and measurable improvements after food for-
tification in micronutrient status and health
outcomes in women and children in wide geo-
graphic settings in LMIC. 15 Fortifying with
319
vitamin A was estimated to reduce the prevalence
of deficiency in children less than 5 years from
33.3% to 25.7% globally; effectively fortifying
with iron would reduce anemia by 14%; salt iodi-
zation has reduced goiter by 40% in countries
such as Pakistan; and fortifying flour with folic
acid has reduced NTDs by 40% to 50%.15
In spite of the efficacy of rice as a suitable
food to be fortified, there is still only limited
evidence for its effectiveness.23 Japan has forti-
fied grains to add to rice before being cooked
since decades ago (on the market since 1981).47
In Costa Rica, mandatory rice fortification with
folic acid, vitamin B1 (thiamine), vitamin B3 (nia-
cin), vitamin B12 (cobalamin), vitamin E, sele-
nium, and zinc has been in place since 2001.
Rice differs from other fortified food staples,
such as maize or wheat, in that the grain needs
to be fortified directly rather than the subproducts
(eg, flour or porridge).48,49 The reduction of
NTDs in Costa Rica is attributed to its experi-
ences with food fortification in general, its cen-
tralized rice industry, government leadership, and
private sector support.50 Detailed rice fortifica-
tion guidelines are in development,51,52 and cur-
rently, a Cochrane systematic review of the
fortification of rice with vitamins and minerals
for addressing micronutrient malnutrition is
underway.53
Effectiveness of Biofortification
The primary evidence for the effectiveness of
biofortification comes from provitamin A–rich
orange-fleshed sweet potato in large randomized
controlled trials, reaching 24 000 households in
Uganda and Mozambique from 2006 to 2009.54-56
Introduction of orange-fleshed sweet potato in
rural Uganda resulted in increased vitamin A
intakes among children and women and improved
vitamin A status among children. Women who
got more vitamin A from the crop also had a
lower likelihood of having marginal vitamin A
deficiency.55 In addition, recent research on the
health benefits of biofortified orange-fleshed
sweet potato in Mozambique showed that biofor-
tification can improve child health; consumption
of biofortified orange sweet potato reduced the
320
prevalence and duration of diarrhea in children
younger than 5 years.57
Economics of Food Fortification
Assessing monetary benefits across a range of
countries is challenging mainly because these
benefits are driven by savings in access to health
care and costs of providing health care. Other
costs related to the intervention may include fac-
tors such as transport. In spite of these caveats,
food fortification has been recognized as one of
the most cost-effective (note 1) interventions to
address nutrient deficiencies in public health; for
instance, top economists gathered at the Copen-
hagen Consensus consistenly ranked food fortifi-
cation as one of the top 4 priority development
interventions.58 Depending on the setting and
micronutrient, cost-effectiveness of fortification
has been estimated between $22 per disability-
adjusted life year (DALY) saved for iron fortifi-
cation in East Africa to $140 per DALY saved for
iron fortification in Latin America,9 while the
cost-effectiveness of fortifying staple foods with
vitamin A may be as high as US$81 per DALY.
The cost–benefit (note 2) ratio of fortification
depends on various other factors, such as defi-
ciency trends, resources, food vehicle, and forti-
ficants used. Because these costs are higher in
high–middle income and high-income countries,
the cost–benefit ratio of fortification tends to be
higher in these countries. Therefore, the cost–
benefit and cost-effectiveness will vary depend-
ing on the food vehicle and micronutrient being
reviewed. Nevertheless, after a thorough review
of costs and benefits, the Copenhagen Consensus
proposed micronutrient fortification, particularly
iron fortification of staples and salt iodization, as
one of the “best-buys” among the 30 interven-
tions they considered for addressing the 10 great
challenges facing global development.6
Keeping in mind the previously mentioned
caveat related to different health benefits due to
differences in the severity and spread of a given
micronutrient deficiency, in a review presented at
the #Future Fortified summit, Horton et al esti-
mated that the median benefit–cost ratio (note 3)
of iron fortification in 10 countries with high lev-
els of anemia is 8.7:1.15 Iodization of salt had a
Food and Nutrition Bulletin 39(2)
benefit–cost ratio of around 30:1, while for folic
acid, the range extended from 11.8:1 in Chile to
30:1 in South Africa.15 For an annual cost of $286
million, the Copenhagen Consensus estimated the
corresponding benefits would be $2.7bn (a bene-
fit–cost ratio of 9.5:1).5
Economics of Biofortification
For biofortification, the cost-effectiveness will be
dependent on the crop, micronutrient, and deliv-
ery country.31 Cost-effectiveness data are cur-
rently available for orange-fleshed sweet potato
in Uganda, where biofortification was demon-
strated to cost US$15 to US$20 per DALY saved,
which the World Bank considers highly cost-
effective.31,59
Results of cost-effectiveness studies have
shown that for each of the country–crop–micro-
nutrient combinations considered, biofortifica-
tion is a cost-effective intervention based on
cost per DALY saved, using World Bank stan-
dards.60 The Copenhagen Consensus concluded
that for every dollar invested in biofortification,
as much as US$17 of benefits may be gained.5
Overview of Large-Scale Food Fortification
Programs
Large-scale food fortification refers to the pro-
duction capacity (more than 50 metric tons/d),
often a prerequisite for mass fortification, which
refers to the reach of a fortified product. The
process involves the addition at central level or
point of production of 1 or more micronutrients to
foods commonly consumed by the general popu-
lation, such as grains, salt and condiments, sugar,
or edible oil, and is usually mandated and regu-
lated by the government sector, in response to
evidence of micronutrient deficiencies or where
a population, or subpopulation, may benefit.
These efforts are concentrated on the organized
food processing sector among large- and
medium-sized industries.
Many food vehicles have been mandated for
fortification with programs that have gone to
scale. For example, by the end of 2017, over
140 countries implemented national USI pro-
grams, more than 90 nations had mandatory
Osendarp et al
fortification programs for at least 1 kind of cereal
grain (wheat, maize, or rice), and over 50 man-
dated the fortification of edible oils, margarine, or
ghee. Sugar is fortified in a smaller number of
countries. Progress on a range of indicators for
large-scale food fortification programs of salt,
staples, and edible oils is regularly monitored and
updated by a recently launched online tool (http://
fortificationdata.org/#data).61
In 2017, there were 75 countries (plus the
Indian Punjab province) with mandatory legisla-
tion to fortify wheat flour, 16 countries to fortify
both wheat and maize flour, and 1 country
(Rwanda) to fortify only maize flour, specifically
with iron and folic acid (see Figure 1). In addi-
tion, 5 countries (Democratic Republic of Congo,
Gambia, Namibia, Qatar, and United Arab Emi-
rates) fortify at least half their industrially milled
wheat flour with iron and/or folic acid through
voluntary efforts.61 Although it is estimated that
48% of industrially milled maize flour is cur-
rently fortified,61 one of the main challenges to
reach large segments of the population with a
fortified product is that many consumers, partic-
ularly in Africa, largely consume locally pro-
duced, unprocessed (and hence unfortified)
maize meal or wheat flour milled at the village
level or in small-scale hammer mills.62 Conse-
quently, the number of small mills without forti-
fication technology in a country will affect
whether the fortification of maize or wheat flour
is a feasible option for that particular country.62
Of the 222 million metric tons of rice that are
industrially milled each year, less than 1% are
fortified with essential vitamins and minerals.
Currently, 8 countries (Costa Rica, Nicaragua,
Panama, Venezuela, India, Papua New Guinea,
the Philippines, and the United States) have man-
datory rice fortification,61 and Brazil, Colombia,
and the Dominican Republic have large-scale
nonmandatory rice fortification programs.23
The USI is the preferred strategy for the con-
trol of iodine deficiency disorders in most coun-
tries.63 Salt has been the vehicle of choice for
fortification as it is consumed by nearly everyone
at roughly equal amounts throughout the year and
is relatively cheap/inexpensive (less than
US$0.02-US$0.10 per person per year). For salt
iodization, there is global information on
321
legislation, coverage, and status (at least in chil-
dren), in contrast to other food fortification pro-
grams, for which most of the information is
limited to the legislation and coverage from a few
countries. Salt production is often limited to a few
centers, which facilitates QC, and the addition of
potassium iodate or potassium iodide does not
affect the taste or smell of the salt.64 Iodine defi-
ciency has been considerably reduced due to iodi-
zation of salt and is now recognized as one of the
great public health nutrition achievements.64,65
The world has moved from 110 countries iodine
deficient in 1993 to now only 19 deficient coun-
tries.38 Nevertheless, although there is recogni-
tion of the importance of iodization of salt,
some 30% of LMIC households are still not con-
suming iodized salt in households, with espe-
cially low coverage in some European and
Central European countries, in South Asia, and
some Sub-Sahara African countries.65
Following national-level documentation of
widespread vitamin A deficiency in large sectors
of the population, carried out in 1965 to 1966,
sugar was legislated for fortification with vitamin
A in Guatemala, Honduras, and El Salvador early
in the 1970s. Sugar was chosen as the most appro-
priate food vehicle because of its high and stable
daily consumption by the population at large,
including vulnerable target groups, and its indus-
trialized, centralized processing that facilitated
adding the vitamin at minimal cost and under
close supervision. Public–private partnerships
were established to work toward the establish-
ment of national programs, supported by a careful
advocacy and promotion campaign. Mandatory
fortification legislation was decreed in each of
the countries for both domestic and industrial use.
Evaluations from each of the countries showed
that these programs had great success in improv-
ing vitamin A intake.66
Edible oils are consumed by almost everyone,
usually, at uniform rates in particular regions
(10-20 g/d in African countries and up to 70-90
g/capita/d in Asia), 40 which makes them an
attractive vehicle for fortification. Fortification
programs for vitamin A in edible oils are cur-
rently in place in 50 countries worldwide (see
Figure 2).61 Of these 50, well over half have man-
datory fortification of margarine and/or oils,
322
Figure 1. Countries with mandatory or voluntary cereal grain fortification in 2017.61 Yellow countries have mandatory legislation for wheat flour; green countries
have mandatory or voluntary fortification of wheat and maize flour.
 Figure 2. Low–middle–high income countries with mandatory or voluntary oil fortification in 2017.61 Green countries have mandatory or voluntary oil
fortification.

323
324
whereas 8 programs are described as “industry
led” (or voluntary), 1 in which it is permitted and
7 where it was not specified. 40 Importantly,
around half of those with mandatory fortification
are in LMIC.
Components of Successful Food Fortification
Programs
A recent review on the coverage and utilization
of food fortification programs in 8 countries
(Bangladesh, Cote d’Ivoire, India [Rajasthan],
Nigeria, Senegal, South-Africa, Tanzania, and
Uganda) identified some successful fortification
programs, whereby the majority of the food
vehicle used was fortifiable and fortified, and
coverage was equitable in reaching the entire
population.67 Programs in some other countries
were identified with potential for effective for-
tification, largely based on very high use of a
fortifiable food vehicle (note 4) by the entire
population, but that potential was not currently
being reached because of low compliance with
fortification requirements.68 Four key lessons
for successful programs were learned: (1) the
potential for impact will depend on the appro-
priate choice of food fortification vehicle and on
the proportion of the food vehicle consumed that
is fortifiable; (2) the design of fortification pro-
grams should be informed by the magnitude and
distribution of inadequate intake and deficiency
and consumption of fortifiable foods, in addi-
tion, food fortification programs should be part
of national micronutrient deficiency control
strategies to ensure coordination with other pro-
grams; (3) effective QC of fortification levels in
foods needs strengthening of capacity and
resources, as well as governance and policy
commitment; and (4) to ensure safe and impact-
ful programs, periodic reviews of the assump-
tions related to dietary patterns that underpin
food fortification are needed.67
In a similar review on successful staple food
fortification programs in Latin America, institu-
tional research capacity and champions of fortifi-
cation, as well as private/public partnerships,
were considered key features of successful and
sustainable programs.66,69
Food and Nutrition Bulletin 39(2)
Successful programs are built on multisec-
toral foundations that include government, pri-
vate sector, international organizations, civil
society, and academia and which have worked
together to generate evidence identifying the
need, setting standards, ensuring legislation and
alignment with national nutrition policies,
ensuring QA and control throughout the manu-
facturing processes, and establishing strong
monitoring and evaluation to ensure compliance
and impact (see Figure 3).17,66,70
Fortification can be either mandatory or vol-
untary, and in both cases, appropriate standards—
as set by WHO—are required to ensure impact
and safety.12 For mandatory fortification to work,
consistent and effective monitoring to ensure
both QA and QC during product manufacturing
and distribution, as well as consumption by the
target population, are necessary.70 Procedures on
good manufacturing practice are available
through ISO and are described in the WHO/FAO
guidelines.12 In addition, monitoring and evalua-
tion to assess the degree to which the fortified
food is actually reaching households and individ-
uals need to be in place in order to address issues
of potential for impact and utilization across dif-
ferent population subgroups. It is also critical for
providing program planners and policymakers
with the necessary information to make decisions
about course correction, scaling up, or even end-
ing of a program.70
Poor Program Performance and Monitoring
of Fortification Programs
A review of external QA activities in GAIN-
supported staple food fortification programs in
25 countries found that the percentage of foods
meeting national standards ranged from 18% to
97%, with an average around 45% to 50%.71
Many nonfortified foods were found to be
labeled as fortified, further misleading consu-
mers on vitamin and mineral content and contri-
buting to a reduced health impact of fortification
programs as a result of foods not appropriately
fortified.72 It must be noted that classifying sin-
gle samples as in or out of range may overesti-
mate the level of noncompliance of fortification
programs because the minimum content is
Osendarp et al
Figure 3. Impact model for staple food fortification.17
highly variable depending on a range of factors.
Nonetheless, 5 underlying issues were described
that are leading to poor program performance
and possibly poor compliance in these 25 coun-
try programs.73
Food laws and regulations related to monitor-
ing, inspection, and enforcement of food fortifi-
cation are often fragmented and not appropriately
embedded within legal frameworks, leading to a
lack of—or weak—enforcement.
Food fortification is not prioritized in food
safety and QC practice and culture, especially
where resources are limited. Over 80% of gov-
ernment respondents noted that their current
funding was not sustainable over the next 5 years.
There is a perceived or real political risk in
enforcing compliance with regulations. Even
where resources and capacity exist, over 60% of
respondents thought that regulatory agencies are
often unwilling to enforce regulations due to per-
ceived or actual resistance from interest groups.
The additional costs to industry to fortify may
lead to some industries lacking appropriate inter-
nal budget and expertise to fortify appropriately
while others purposely underfortify.
Regulatory monitoring agencies and consumer
protection groups often do not actively protect
325
consumers from underfortified or nonfortified
foods, or fraudulent labeling, thereby misleading
consumers who should be able to trust what is
stated on packages in relation to vitamin and
mineral content.
Given the possibility of over consumption of
nutrients in groups outside the target population,
identifying additional intakes and nutritional status
associated with the consumption of fortified foods
should be actively and consistently monitored as
an integral part of any fortification program.44,71 In
China, careful monitoring has identified counties
where much of the population is likely getting too
much iodine from the local water source as judged
by urinary iodine levels, and in these areas, iodine
is being reduced in the iodized salt distributed.74
Similarly, in Ireland, mandatory folic acid fortifi-
cation of bread was reconsidered in 2008 because
of concerns of excessive intakes due to the high
intakes of voluntarily fortified foods.75 Using
modeling techniques for fortificants, 1 study con-
cluded that the adoption of fortification content for
staple foods near the safe limit also brings into
consideration the need for restricting the voluntary
addition of the specific nutrient to other foods and
to dietary supplements,76 especially where the risk
of deficiency is not universal.77
326
Many national programs are currently not
achieving national targets, especially in iodine
“because of weak regulatory/monitoring systems”
(Yusafali, MSc, personal communication, 2015).
Setting up effective monitoring systems and tools
for assessing QC and compliance, as well as set-
ting up rigorous impact evaluations, requires a
thorough understanding of the different pathways
leading to effective coverage and impact. Insuffi-
cient budgets are often identified as constraining
adequate QC and compliance.72
Challenges of Large-Scale Food Fortification
Although long experience and numerous studies
and reports attest to fortification’s effectiveness
and feasibility,12,78,79 the following challenges do
remain.
Evidence gaps. Evidence gaps remain in assessing
the potential for impact on public health out-
comes and how to effectively measure these. Pro-
gram impact evaluations should be guided by
impact pathways, prioritizing impact assessment
in programs with an appropriate design and imple-
mentation to substantially increase the quality of
evidence.80 Although the effectiveness of food for-
tification on nutrient intakes and nutrient status is
largely established, there is still insufficient evi-
dence of effectiveness on functional outcomes,
including growth, cognitive development, morbid-
ity, and mortality, especially in LMIC.18,81 This is
especially an issue, as much emphasis is currently
being placed on the prevention of stunting. The
translation of evidence into realistic target settings
for policies and programs is often lacking. In addi-
tion, changes in dietary habits over time may
results in challenges, as in the case of decreasing
consumption of iodized table salt in Europe,82 as
well as opportunities, such as in the case of for-
tified breakfast cereals now being the dominant
source of iron in UK schoolchildren.19
In a recent WHO/FAO Technical Consultation
on scaling up rice fortification in Asia,83 the fol-
lowing research gaps on technical issues were
identified: (1) assessing the stability of different
micronutrients in different context-specific envir-
onments; (2) studying the nutrient–nutrient inter-
actions, in particular related to relative
Food and Nutrition Bulletin 39(2)
bioavailability and phytate effect on iron absorp-
tion; and (3) evaluating the optimal delivery plat-
forms for reaching the (hard to reach) target
populations.
Finally, although mandated programs usually
cover only registered producers, small-scale mills
remain the predominant source of (iron-fortified)
wheat and maize flours in many rural subsistence
farming areas, while small-holding salt produc-
tion units require small batch iodization. In 2015,
United Nations Children’s Fund, GAIN, IGN, and
NI completed a review of country experiences in
small-scale salt fortification, with a smaller focus
on wheat and maize fortification. The study iden-
tified number of evidence gaps and challenges for
this type of food fortification, including clarity on
small-scale contribution to supply; possibility of
industry consolidation or quasi-consolidation in
the form of cooperatives; understanding social
impact; identifying incentives, models of cooper-
ation, business plan development, and appropri-
ate inputs for external support; establishing
minimum criteria for quality; and understanding
market forces and competition.17
Ensuring effective coverage. Effective coverage is
defined as the proportion of the population who
utilize an intervention as per intended to achieve a
biological/health impact.84 For food fortification,
this could be interpreted as the proportion of the
population consuming adequately fortified
food.85 Effective coverage is a precondition for
impactful programs, along with other factors as
described in this article. Challenges in reaching
impact have been described from the very early
days of large-scale fortification programs in the
United States, and such challenges, including
the choice of appropriate fortification vehicles,
the use of a bioavailable fortificant, not reaching
populations most likely to benefit, avoiding over
consumption in nontargeted groups, and adequate
monitoring of nutritional status, currently still
exist in all countries.44 To support assessments
of effective coverage in both population-based
and targeted fortification programs, GAIN devel-
oped a Fortification Assessment Coverage
Toolkit (FACT). An 8-country series of FACT
coverage surveys were completed between 2013
and 2015 and assessed coverage (including equity
Osendarp et al
aspects) of 18 identified large-scale fortification
programs. Coverage varied widely by food vehi-
cle and country, and the 2 main program bottle-
necks were a poor choice of vehicle and failure to
properly fortify a fortifiable vehicle (ie, the
absence of adequate fortification).68
Accessibility and equity. One of the criticisms of
mass fortification is that it may not be accessible
to those most in need. Commercially fortified
products may not be affordable for the poorest
segments of societies, partly because in some
countries import duties and taxes on premixes or
fortification equipment drive prices up. Inequity in
access to fortified foods needs to be locally
researched and contextually understood, as reasons
for lack of accessibility will differ within countries
and within households. Programs often lack such
particular understanding and do not assess intra-
household food distribution practices, which are
often disadvantaging women and young children
within households.86,87 To effectively reach popu-
lations most in need, opportunities to link with, for
example, social protection programs, need to be
explored and better utilized.
Conclusions and Recommendations
Food fortification is one of several evidence-
based interventions that improve the overall qual-
ity of the diet, working through existing delivery
systems. In addition, in recent years, biofortifica-
tion has been shown as a promising, feasible, and
cost-effective means of delivering micronutrients
to populations who may have limited access to
diverse diets and other micronutrient interven-
tions, and efforts are underway to scale up its use
to further improve global nutrition. 31 It is
important to acknowledge that, although food
fortification programs are highly efficient and
cost-effective, to ensure sustained impact they
require continued interest and investment by gov-
ernments for monitoring of delivery. In addition,
investments by donors for both existing and new
programs can further improve fortification’s foot-
print and impact. Large-scale food fortification
and biofortification should be integrated into
nutrition-specific and nutrition-sensitive efforts
to prevent and control micronutrient deficiencies.
327
In the past 2 decades, large-scale food fortification
programs have been reaching increasingly large
segments of populations in LMIC, paired with an
acceleration of knowledge and guidance on large-
scale fortification. Yet, a number of technical and
food system challenges remain, especially in rela-
tion to improving coverage and quality of delivery
and to measuring the progress of national pro-
grams. Tackling these issues in a concerted man-
ner, as articulated in the 2015 Arusha Statement on
Food Fortification,15 can help to further accelerate
progress and potential of impact.
Authors’ Note
SJMO conceptualized the manuscript with IDH, LMN,
HM, and GG and wrote the first draft of the manuscript.
IDH performed the literature review, and IDH, LMN,
MV, SJMO, and HM authored the review report enti-
tled “Large-scale food fortification: an overview of
trends and challenges in Low and Middle-Income
Countries in 2017” which was the basis for this manu-
script. All authors provided substantial technical and
editorial input in the draft versions, and reviewed and
approved the final manuscript.
Acknowledgments
The authors would like to acknowledge the contribu-
tion of Rafael Flores-Ayala to help scope this paper as
well as his comments to an earlier version.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest
with respect to the research, authorship, and/or publi-
cation of this article.
Funding
The author(s) received no financial support for the
research, authorship, and/or publication of this article.
ORCID iD
Homero Martinez http://orcid.org/0000-0002-1435-
0306
Notes
1. The denominator in this ratio is gain in health
(expressed, for example, as years of life saved,
disability-adjusted life years [DALYs], or micronu-
trient status and its links to morbidity/mortality out-
comes) and the numerator is the cost associated
with the health gain.
328
2. An indicator that summarizes the value for money
of a proposal; both costs and benefits are expressed
in monetary terms.
3. The inverse of cost–benefit.
4. According to World Health Organization and the
United Nations Food and Agriculture Organization
guidelines (2006), a food vehicle suitable for forti-
fication refers to a food that is widely consumed in
relatively constant quantities by the target popula-
tion, available all year round, of relatively low cost,
centrally processed, and with no interactions
between the fortificant and the carrier food.12
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